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October 12, 2017

Last month, we reported on a decision in Natural Alternatives International, Inc. v. Allmax Nutrition, Inc., in which District Judge Marilyn L. Huff of the U.S. District Court for the Southern District of California denied a Motion for Reconsideration filed by Natural Alternatives International, Inc. ("NAI"), and determined that NAI's claim for patent infringement remained dismissed with prejudice. NAI had initiated the dispute against Allmax Nutrition, Inc. ("Allmax") by alleging, inter alia, that Allmax infringed U.S. Patent Nos. 5,965,596; 7,504,376; 7,825,084; and RE45,947 by offering to sell and selling dietary supplements containing beta-alanine.

The patents-in-suit are directed to compositions, dietary supplements, and methods of regulating hydronium ion concentrations in a subject/human. In particular, representative claim 1 of the '596 patent recites:

1. A method of regulating hydronium ion concentrations in a human tissue comprising: providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue; and exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the human tissue.

Representative claims 1, 7, 8, and 11 of the '376 patent recite:

1. A composition, comprising: glycine; and a) an amino acid selected from the group consisting of a beta-alanine, an ester of a beta-alanine, and an amide of a beta-alanine, or b) a di-peptide selected from the group consisting of a beta-alanine di-peptide and a beta-alanylhistidine di-peptide.

1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement provides a unit dosage of beta-alanine.

5. A composition for increasing beta-alanylhistidine dipeptide in a subject, comprising a mixture of creatine and anserine or balenine in an amount for increasing beta-alanylhistidine dipeptide in a subject.

9. A dietary supplement, comprising a mixture of creatine and anserine or balenine.

13. A method of regulating hydronium ion concentration in a tissue of a subject, comprising administration of a composition comprising a mixture of creatine and anserine or balenine to the subject to increase beta-alanylhistidine dipeptide synthesis in a tissue, whereby the anaerobic working capacity of the tissue is increased.

Representative claims 34 and 35 of the '947 patent recite:

34. A human dietary supplement for increasing human muscle tissue strength comprising a mixture of creatine, a carbohydrate and free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide, wherein the human dietary supplement does not contain a free amino acid L-histidine, wherein the free amino acid beta-alanine is in an amount that is from 0.4 g to 16.0 g per daily dose, wherein the amount increases the muscle tissue strength in the human, and wherein the human dietary supplement is formulated for one or more doses per day for at least 14 days.

35. A human dietary supplement for increasing human muscle tissue strength comprising a mixture of creatine monohydrate, a carbohydrate and free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide, wherein the human dietary supplement does not contain a free amino acid L-histidine, wherein the free amino acid beta-alanine is in an amount that is from 0.4 g to 16.0 g per daily dose, wherein the amount increases the muscle tissue strength in the human, and wherein the human dietary supplement is formulated for one or more doses per day for at least 14 days.

After forcing NAI to file two amended complaints, resulting in the addition of HBS International Corp. ("HBS") as a Defendant, Allmax filed a motion for judgment on the pleadings pursuant to Fed. R. Civ. P. 12(c) and HBS filed a motion to dismiss pursuant to Fed. R. Civ. P. 12(b)(6). After filing an opposition to both motions, NAI filed its own motion for judgment on the pleadings.

In its motion for judgment on the pleadings, NAI argued that Allmax was precluded from asserting an affirmative defense and counterclaim that all asserted claims from the patents-in-suit were invalid because Allmax and HBS were parties to separate license agreements with NAI containing provisions that prohibited them from contesting the validity of NAI's patents. In denying NAI's motion, the District Court determined that the no-contest provisions in the license agreements were unenforceable under Lear, Inc. v. Adkins, 395 U.S. 653 (1969), since the agreements were entered into prior to any litigation between the parties.

In their Rule 12 motions, Allmax and HBS sought to have NAI's claims for violation of Lanham Act § 32, patent infringement, and civil conspiracy dismissed. With regard to NAI's patent infringement claim, Allmax and HBS argued that the claim should be dismissed because the patents-in-suit are invalid under 35 U.S.C. § 101 as failing to claim patent eligible subject matter. In assessing the validity of the patents-in-suit, the District Court focused on claim 1 of the '084 patent, claim 1 of the '596 patent, claim 34 of the '947 patent, and claim 6 of the '376 patent, each of which were specifically referenced in NAI's amended complaint and discussed in Defendants' Rule 12 motions. Because NAI's opposition to Defendants' Rule 12 motions did not contest Defendants' focus on these four representative claims, and NAI's own § 101 analysis focused on the same four claims, the District Court focused on the same four claims.

In determining whether the four representative claims fall outside the scope of § 101, the District Court applied the two-stage framework set forth by the Supreme Court in Alice Corp. Pty. v. CLS Bank Int'l, 134 S. Ct. 2347, 2355 (2014). In particular, the District Court determined (1) whether the claim is directed to a patent-ineligible concept, i.e., a law of nature, a natural phenomenon, or an abstract idea, and if so, (2) whether the elements of the claim, considered both individually and as an ordered combination, add enough to transform the nature of the claim into a patent-eligible application.

With regard to representative claim 1 of the '084 patent, the District Court noted that beta-alanine is the only ingredient of the claimed human dietary supplement, and that the '084 patent specification discloses that beta-alanine is an amino acid that is present in the muscles of humans and other vertebrates. According to the Court, "the '084 patent acknowledges that beta-alanine is a natural occurring phenomenon," and therefore "claim 1 of [the] '084 patent is directed to excluded subject matter — specifically beta-alanine, a natural phenomenon — thereby satisfying step one of the Alice inquiry." Noting that " the inventive concept described in claim 1 of the '084 patent is placing a specific dosage of beta-alanine into a human dietary supplement," and further that "[t]he '084 patent acknowledges that placing a natural substance into a dietary supplement is conventional activity," the Court concluded that "employing a dietary supplement to administer the beta-alanine, a natural phenomenon, is insufficient to render claim 1 patent eligible." The Court therefore determined that representative claim 1 of the '084 patent is directed to patent-ineligible subject matter, and thus is invalid under § 101.

With regard to representative claim 34 of the '947 patent, the District Court noted that claim 34 is directed to a human dietary supplement containing a mixture of beta-alanine, creatine, and a carbohydrate, and that each of these substances is a naturally occurring phenomenon. Finding that claim 34 is directed to excluded subject matter, the Court proceeded to step two of the Alice inquiry. With respect to its step two analysis, the Court explained that:

In Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130-31 (1948), the Supreme Court held that mixing different natural phenomena together — specifically, in that case different bacterial species — is insufficient to render an invention patent eligible even though it was not previously known that the substances could be mixed together, and the combination provided certain advantages. Thus, in the present case, mixing beta-alanine, a natural phenomenon, with a carbohydrate and creatine, two other natural phenomena, and placing that mixture in a human dietary supplement, a conventional activity, is insufficient to render claim 34 patent eligible. . . . Accordingly representative claim 34 of '947 patent is directed to patent-ineligible subject matter, and, thus, is invalid under 35 U.S.C. § 101.

Representative claim 6 of the '376 patent depends from claim 5 of the '376 patent, which in turn depends from claim 1 of the '376 patent. Claim 1 of the '376 patent is set forth above, and claims 5 and 6 of the '376 patent recite:

5. The composition of claim 1, wherein the composition is a dietary supplement or a sports drink.

6. The composition of claim 5, wherein the dietary supplement or sports drink is a supplement for humans.

The District Court's analysis of claim 6 of the '376 patent was similar to its analysis of claim 34 of the '947 patent. In particular, the Court noted that claim 6 recites a human dietary supplement containing a mixture of beta-alanine and glycine, each of which is a naturally occurring phenomenon. Determining that step one of the Alice inquiry was satisfied for claim 6, the Court then determined that:

Finally, with regard to representative claim 1 of the '596 patent, the District Court noted that it "agrees with Defendants that this claim is directed to a law of nature, specifically the principle that ingesting beta-alanine, a natural substance, will increase carnosine concentration in tissue and, thereby, aid in regulating the hydronium ion concentration in the tissue." Moving to step two of the Alice inquiry, the Court stated that:

[T]he elements contained in claim 1 of '596 patent do not disclose an inventive concept sufficient to transform the claimed law of nature into a patent-eligible application. The Court agrees with Defendants that the language in claim 1 does nothing more than simply state the law of nature and add the words apply it to human tissue. Specifically, the language in claim 1 simply acknowledges the natural law that providing beta-alanine to human tissue will increase the carnosine concentration in the tissue and aid in regulating hydronium ion concentration, and then merely instructs to do so. This is insufficient to render the claim patent-eligible.

In response to NAI's argument that claim 1 is directed to eligible subject matter because the claimed method increases the carnosine content in the tissue through a non-natural process, the Court indicated that:

There is nothing in the claim language requiring that the carnosine concentration achieved by the method be at unnatural levels. Moreover, there is nothing in the claim language requiring that the beta-alanine used in the method come from non-natural sources, and, thus, the claim appears to encompass natural methods of exposing beta-alanine to human tissue and, thereby, increasing the carnosine content in the tissue.

The District Court therefore concluded that representative claim 1 of the '596 patent is directed to patent-ineligible subject matter, and thus invalid under 35 U.S.C. § 101.

Having determined that all four representative claims from the patents-in-suit are directed to patent-ineligible subject matter, and therefore invalid under § 101, the District Court granted Defendants' Rule 12 motions and dismissed NAI's claim for patent infringement.

Comments

Any decision citing Funk Brothers without attention to the detailed circumstances of that case and the actual holding is inherently highly suspect. In truth, Funk Brothers was about inventive step now 103 not eligibility now 101. Also you have to appreciate that the claim there covered all mixtures of non-interfering bacteria without disclosure in the specification of any specific bacteria that could be mixed together and would perform as described.

Disregarding dosage requirements is also highly suspect on the all elements rule.

The patent-ineligibility ruling in this case is absurd-unit dosage form claims have existed for decades. More evidence that the nonsensical Mayo/Alice framework is broken. If only Congress would listen and neuter this absurd SCOTUS standard for patent-eligibility.

I profoundly agree with Skeptical regarding the "all elements" rule and the words "directed to" which are apt to be distorted to "focus". The court constructs a straw man by paraphrasing the claim and then judges the straw man of its own creation rather than the reality of the subject matter claimed.

The point was strongly made in my amicus brief to the Federal Circuit in Recognicorp, which so far unfortunately has cur no ice.